Regulatory Affairs Specialist I/EU MDR Support Specialist

Job DescriptionResponsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s} and communication of general regulatory requirements in support of licensing of Baxter's products. Serves as a consultam to managers. Manage regulatory activities relating to specific global portfolio of products/projects.Essential Duties & Responsibilities• Initiate and develop complex regulatory project plans• Identify & prioritize key areas of regulatory risk• Provide regulatory device to project teams.• Respond to complex questions from regulatory authorities within strict timelines• Compile and submit in a timely manner, regulatory documents according to regulatory requirements• Maintain and update device listing regulatory authorizations• Manage regulatory activities relating to specific portfolio of products/projects• Prepare, review. and approve labeling and SOP• s• Lead or represent Regulatory Affairs in project teams• Provide guidance and coaching for areas of responsibility to lower level team members• Monitor applicable regulatory requirements• Create and maintain regulatory files in a format consistent with requirementsQualifications:• Knowledge of regulations• Solid Understanding of EU MDR and ancillary directives• Scientific knowledge• Project management skills• Manage multiple projects , and deadlines• Ability to multitask and prioritize• Interpersonal and communication skills• Strong negotiation skills• Technical system skills (e.g. word processing, spreadsheets, databases, online research)• Ability to work effectively in multinational/multicultural environment• Ability to identify compliance risks and escalate when necessaryEducation / Experience:Bachelor's degree or country equivalent in a scientific discipline